Promethazine, chlorpheniramine, astemizole and ceteirizine

Antihistamine medicaments (promethazine, chlorpheniramine, astemizole, cetirizine)

MEFCC CLEARANCE

HSN 3004 90 31 (promethazine, chlorpheniramine, astemizole and cetirizine) is subject to the Central Drugs Standard Control Organisation (CDSCO) drug registration and import licensing regime under the Drugs and Cosmetics Act, 1940. The Directorate General of Foreign Trade (DGFT) administers the ITC (HS) import policy overlay, including the prohibition on oxytocin imports under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022 — a restriction that applies across CTIs in this sub-heading.

What this is

HSN code

3004 90 31

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
Batch release certificate from CDSCO

Applicable Partner Government Agencies

MEFCCMEFCC·Ministry of Environment, Forest and Climate Change

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade.

Compliance steps

1
Obtain a valid drug registration certificate (document code 101dc1) and import licence for drugs (document code 9111dc) from the Central Drugs Standard Control Organisation before filing the bill of entry. Both documents must be uploaded in e-Sanchit and their currency confirmed at the time of out-of-charge.
Drugs and Cosmetics Act, 1940 · document codes 101dc1 and 9111dc
2
Upload in e-Sanchit the full set of mandatory documents: Certificate of Analysis for drugs (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for drugs (101dc1), and Import Licence for drugs (9111dc). The proper officer verifies all five before granting out-of-charge on PGA-facilitated bills.
CBIC CCR e-Sanchit mandatory document requirement · document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
3
Confirm the consignment contains none of the oxytocin-class substances prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022. Import of oxytocin reference standards is permitted only for test and analysis, subject to a test licence from DCGI/CDSCO.
S.O. 2357(E) dated 23-05-2022 · DGFT Notification 09/2015-2020 dated 23-05-2022

A word of counsel

The most common error on this tariff line is presenting only the drug registration certificate at the bill of entry while omitting the batch release certificate (0030dc) or the label of consignment document (0110dc). All five mandated e-Sanchit uploads are independently verified by the proper officer before out-of-charge is granted; a missing batch-level document — even when the registration is current — triggers detention and demurrage at the port of entry.

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Frequently asked

Does HSN 3004 90 31 require BIS certification?

No, antihistamine medicaments under this tariff line are not subject to any BIS Quality Control Order. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with DGFT administering the ITC (HS) import policy overlay including the oxytocin prohibition under S.O. 2357(E).

Which document codes must be uploaded in e-Sanchit before out-of-charge?

Five documents are mandatory: Certificate of Analysis for drugs (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for drugs (101dc1), and Import Licence for drugs (9111dc); all must be present in e-Sanchit before the proper officer grants out-of-charge.

Is import of oxytocin permitted under this tariff line?

Import of oxytocin is prohibited under S.O. 2357(E) and DGFT Notification 09/2015-2020 dated 23-05-2022; the sole exception is import of oxytocin reference standards exclusively for test and analysis, which requires a test licence issued by DCGI/CDSCO.

Last verified against gazette notifications: 2026-05-16. Source: MEFCC / DGFT / Indian Customs CUSDATA.